The
purpose of this letter is to request that the Department of Health
and Human Services and the Food and Drug Administration (FDA) consider
giving greater priority to an existing rulemaking concerning the
trans fatty acid content of foods. There is a growing body
of scientific evidence, both experimental and epidemiological, suggesting
that consumption of trans fatty acids in foods increases
the consumers risk of developing coronary heart disease (CHD).
We refer to evidence published in quality medical journals such
as LANCET, ARTERIOSCLEROSIS, THROMBOSIS, AND VASCULAR BIOLOGY, CIRCULATION,
and THE NEW ENGLAND JOURNAL OF MEDICINE. We encourage FDA to review
carefully the public comments on its 1999 proposed rulemaking concerning
consumer labeling of trans fatty acids and, if appropriate, proceed
to a final rulemaking.

As
you know, on November 17, 1999, FDA published a proposed rule entitled
"Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient
Content Claims, and Health Claims". The rule would amend the
current nutrition labeling regulations by requiring the amount of
trans fatty acids present in food to be included in the products
Nutrition Facts panel. The proposal also would create a new nutrient
content claim defining "trans fat free" and require
a limit on trans fatty acids whenever there are limits on
saturated fat in nutrient content claims or health claims. The proposal
was mainly based on studies that indicate that consumption of trans
fatty acids contributes to increased blood LDL-cholesterol levels,
which increase the risk of CHD. As indicated above, recent studies
have strengthened that conclusion and shown that trans fatty
acids may also work through other mechanisms to increase the risk
of CHD.

Based
on assumptions that the proposal will assist consumers in their
efforts to reduce their risk of CHD and provide incentives to producers
to reformulate food products to reduce the trans fat content, FDAs
preliminary Regulatory Impact Analysis estimated that, 10 years
after the effective date, the rule would prevent 7,600 to
17,100 cases of CHD and avert 2,500 to 5,600 deaths per year. Over
a 20-year period, FDA estimated the benefits of the proposed rule
would range from $25 to $59 billion, while the costs were only $400
million to $850 million.

In
light of these estimates and the recent scientific findings, OMB
believes there may be an opportunity here to pursue cost-effective
rulemaking that provides significant net benefits to the American
people. At the time OMB reviewed the proposed rule, OMB was impressed
with the magnitude of the potential net benefits estimated by the
underlying analysis. We understand that FDA has gathered additional
information from the public as part of the public comment period,
and that FDA is in the process of drafting a final rule in response
to the comments received. If the regulatory impact analysis still
suggests that the potential benefits of this rule far exceed the
costs, then I strongly encourage you to finalize this rule or explain
the rationale for not moving it forward. This rulemaking appears
to be a tremendous opportunity for the FDA to address the nations
leading cause of death B coronary heart disease B and to save thousands
of lives.

If
you should decide to submit a draft final rule to OMB for review,
we will conduct a rigorous, careful, and expeditious review. Prior
to the review, my staff is eager to work with you to ensure the
best possible rule and supporting analysis. At your earliest
convenience, my staff would like to meet with FDAs staff to
discuss the comments FDA received on the proposal and the agencys
current thinking on how it plans to proceed.

Sincerely,

/s/

John D. Graham
Administrator
Office of Information and Regulatory Affairs